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Category Archives: Gene therapy
Creating Hope For Orphan Diseases
The Creating Hope Act of 2011, along with advancements in science and a shift in focus for Big Pharma, means that rare and pediatric orphan diseases may finally get the attention they deserve.
“As a society, as we’re having this big debate around healthcare, everyone agrees that there’s a certain baseline of people that we [...]
Also posted in FDA, Regulatory, healthcare Tagged orphan diseases, Orphan Drugs, R&D, rare diseases 1 Comment
NIH Director Speaks Out on the Institutes' New Remit
As the National Institutes for Health hits the headlines over its remit to help develop new medicines, Director Francis Collins talks to Pharm Exec about the new initiatives he sees as critical for innovation, industry and public health.
Francis Collins devoted more than 15 years in the lab to deciphering the human genome. Ten years later, [...]
Also posted in FDA, Guest Blog, IP, R&D, Regulatory, healthcare, leadership Tagged drug development, Francis Collins, innovation, National Institutes for Health, NIH, Public health, translational medicines 1 Comment
Tufts R&D Outlook for 2011: Pain Mixed with Promise
The Tufts Center for Drug Development issues its annual assessment of the state of R&D in Big Pharma, noting that industry faces a cumulative tide of challenges marked by a dramatic reversal in societal attitudes toward risk. Productivity gaps in the pipeline aside, perhaps the biggest problem is political — convincing stakeholders to strive for [...]
Also posted in FDA, R&D, Regulatory Tagged Big Pharma, FDA, forecast, monoclonal antibodies, R&D, risk sharing, Tufts Center for Drug Development 1 Comment
What a Week! Roche and Genentech … and Mirus!?!
The big news this week—and, for that matter, this year—is Roche’s offer to buy the 44 percent of Genentech that it doesn’t already own. The blogosphere is burning with all the predictable predictions, dire and otherwise, attendant on a big pharma takeover of a biotech. The phrase “killing the goose that’s been laying the golden [...]
Bringing Genetic Data into the Clinic